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United States · US · US:65862-602_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d
Modafinil
Orange BookUNIISPLATC N06BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN06BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116586260201100 TABLET in 1 BOTTLE (65862-602-01)
- ndc116586260205500 TABLET in 1 BOTTLE (65862-602-05)
- ndc11658626023030 TABLET in 1 BOTTLE (65862-602-30)
- ndc11658626029090 TABLET in 1 BOTTLE (65862-602-90)
Annotations
UNII (FDA Substance ID)
R3UK8X3U3D
MODAFINIL
RxCUI 30125
Orange Book
A202566
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R3UK8X3U3D",
"rxcui": "30125",
"inchikey": "YFGHCGITMMYXAQ-UHFFFAOYSA-N",
"display_name": "MODAFINIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1d4c6858-5b2f-f216-e063-6394a90aad5d": {
"match": "brand_token",
"title": "MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "3",
"published_date": "2026-03-18"
}
},
"productid": "65862-602_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d",
"productndc": "65862-602",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202566",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 27, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Sep 27, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MODAFINIL",
"proprietary_name": "Modafinil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202566",
"marketing_category": "ANDA",
"nonproprietary_name": "Modafinil",
"start_marketing_date": "20120927",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N06BA07.
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